HRD and Resistance to PAPPi in EOC Patients

NCT ID: NCT05310370

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-26

Study Completion Date

2025-03-26

Brief Summary

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The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients has been investigated in previous studies (NCT04190667 and NCT04651920). This study is to investigate the correlation between HRD and the resistance to poly(ADP-ribose) polymerase inhibitors (PARPi) in a Chinese cohort confirmed of epithelial ovarian cancer. The mutated genes, HRD score model and their relationship with the prognosis is the primary endpoint in this study. All enrolled patients will accept PARPi as maintenance therapy after the complete or partial remission of targeted lesions. A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

Detailed Description

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Conditions

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Epithelial Ovarian Cancer Homologous Recombination Deficiency Homologous Recombination Repair Gene Mutation Poly(ADP-ribose) Polymerase Inhibitor Drug Resistance Progression-free Survival Overall Survival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Testing of homologous recombination deficiency

A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or older
* Pathological confirmation of epithelial ovarian cancer
* With available tumor tissues
* Given consents to participate the study
* With detailed follow-up outcomes

* Declining to accept PARPi as maintenance therapy after the major treatment for cancer
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

86-139-1198-8831

Facility Contacts

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Lei Li, M.D.

Role: primary

8613911988831

Other Identifiers

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EOC-HRD3

Identifier Type: -

Identifier Source: org_study_id

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